Understanding the Market | LEPU BIO-B rose over 4% in early trading as MRG003 is expected to be included in breakthrough therapy designation targeting refractory nasopharyngeal carcinoma

LEPU BIO-B rose over 4% in early trading, as of the time of writing, it increased by 4.11%, priced at HKD 7.34, with a transaction volume of HKD 30.16 million. In terms of news, on September 19, the CDE official website announced that LEPU BIO's EGFR-targeted ADC drug MRG003 is proposed to be included in the breakthrough therapy designation, indicated for use in combination with Pembrilizumab (PD-1 monoclonal antibody) for the treatment of recurrent or metastatic nasopharyngeal carcinoma in patients who have previously failed platinum-based and PD-1/PD-L1 inhibitor treatments. It is reported that MRG003 is currently the leading EGFR ADC drug in global development progress, having previously received breakthrough therapy designation and priority review qualification from the CDE, as well as orphan drug status, fast track designation, and breakthrough therapy designation from the FDA. In September 2024, LEPU BIO initially submitted a marketing application for this drug for nasopharyngeal carcinoma, but later withdrew it voluntarily due to the need for supplementary materials, and resubmitted it in March this year. It is currently included in the priority review process for monotherapy in specific recurrent/metastatic nasopharyngeal carcinoma patients